DEVICE: NAVIGATED INSTRUMENTS;FIREBIRD NXG (18257200119653)

Device Identifier (DI) Information

NAVIGATED INSTRUMENTS;FIREBIRD NXG
36-1329
In Commercial Distribution

Orthofix US LLC
18257200119653
GS1

1
927083808 *Terms of Use
MONOAXIAL SCREW DRIVER, FIREBIRD NAVIGATED, BL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44896 Growth-correction orthopaedic fixation plate kit
A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
OLO Orthopedic stereotaxic instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K172115 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

02a410ca-f928-44ed-a4bc-796e2accf83c
February 19, 2024
3
March 19, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)527-0404
customerservice@orthofix.com
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